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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
Devicecoflex Interlaminar Technology
Generic NameProsthesis, spinous process spacer/plate
ApplicantCompanion Spine France
Immeuble Le Bridge - 5 Allee Des Acacias
Merignac Gironde 33700
PMA NumberP110008
Supplement NumberS004
Date Received01/14/2016
Decision Date02/09/2016
Product Code NQO 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of a second supplier for the instruments with the following part numbers: UAT00008, UAT00010, UAT00012, UAT00014, UAT00016, UBT10008, UBT10010, UBT10012, UBT10014, UBT10016, UAT10100, UAT10200, UAT10300, UAT20100, and UAT20110.
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